Trial Outcomes & Findings for Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer (NCT NCT01860040)

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

One year

Results posted on

2018-02-07

Participant Flow

did not meet recruitment goal

Participant milestones

Participant milestones
Measure	Cisplatin and Pemetrexed Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Pemetrexed	Cisplatin and Gemcitabine Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Gemcitabine
Overall Study STARTED	1	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cisplatin and Pemetrexed Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Pemetrexed	Cisplatin and Gemcitabine Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Gemcitabine
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Neoadjuvant Chemo for Non-metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cisplatin and Pemetrexed n=1 Participants Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Pemetrexed	Cisplatin and Gemcitabine Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Gemcitabine	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: One year

Population: There are no data recordings for this study. The study was terminated and the investigator is no longer related to the site. There is no additional information to provide.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by Magnetic Resonance Imagery (MRI): Complete Response (CR), Disappearance of all target lesions

Outcome measures

Outcome data not reported

Adverse Events

Cisplatin and Pemetrexed

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Cisplatin and Gemcitabine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cisplatin and Pemetrexed n=1 participants at risk Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Pemetrexed	Cisplatin and Gemcitabine Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Gemcitabine
Gastrointestinal disorders vomiting	100.0% 1/1 • Number of events 1	— 0/0

Other adverse events

Other adverse events
Measure	Cisplatin and Pemetrexed n=1 participants at risk Cisplatin on day 1 and pemetrexed on day 1, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Pemetrexed	Cisplatin and Gemcitabine Cisplatin on day 1 and gemcitabine on days 1 and 8, 1 cycle = 21 days, deliver 4 neoadjuvant cycles Cisplatin Gemcitabine
Gastrointestinal disorders nausea	100.0% 1/1 • Number of events 1	— 0/0

Additional Information

Director of Clinical Research

Western Regional Medical Center

Phone: 6232073000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place